RECIST

Can-Fite’s Namodenoson for the Treatment of Pancreatic Cancer Patients: Progress in Clinical Development

Retrieved on: 
Monday, December 4, 2023
Oncology, Professional Services, Health, Finance, Clinical Trials, Pharmaceutical, Biotechnology, Pancreatic cancer, Symantec Endpoint Protection, Dor, NYSE, Safety, CANF, Rabin Medical Center, Treatment, RECIST, Duration, Disease, Liver cancer, RAS, Patient, Inflammation, Growth, PFS, Pharmacokinetics, DCR, Activity, Conference, ORR, Trial of the century, Survival, Phase, Cancer, Rated R, Progression-free survival, TASE, AACR, Pharmaceutical industry

Can-Fite completed the protocol design of the CF102-222PC clinical study entitled: “A Phase II Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma”.

Key Points: 
  • Can-Fite completed the protocol design of the CF102-222PC clinical study entitled: “A Phase II Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma”.
  • This is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least 1st-line therapy or who refuse standard treatment.
  • The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this population.
  • “This Phase IIa study is designed as an open-label one, enabling us to assess the safety and potential efficacy of Namodenoson in pancreatic cancer patients whose disease has progressed despite first-line treatment.

Exelixis Announces Initiation of the STELLAR-305 Phase 2/3 Pivotal Trial Evaluating Zanzalintinib in Combination with Pembrolizumab in Patients with Previously Untreated Recurrent or Metastatic Head and Neck Cancer

Retrieved on: 
Monday, December 4, 2023
Research, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, SCCHN, Neck, Progression-free survival, Head, RECIST, Exelixis, Neoplasm, Patient, PFS, Medical Affairs Bureau, Pembrolizumab, BIRC, ClinicalTrials.gov, Immunotherapy, Pharmaceutical industry

Exelixis, Inc. (Nasdaq: EXEL) today announced the initiation of STELLAR-305, a phase 2/3 pivotal trial evaluating zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced the initiation of STELLAR-305, a phase 2/3 pivotal trial evaluating zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
  • Patients must not have received prior systemic therapy for recurrent or metastatic disease.
  • Patients will be randomized 1:1 to receive zanzalintinib in combination with pembrolizumab or placebo in combination with pembrolizumab.
  • Secondary endpoints include PFS per RECIST 1.1 by investigator and objective response rate and duration of response per RECIST 1.1 by BIRC and by investigator.

Merck KGaA, Darmstadt, Germany Strengthens Oncology Portfolio Through Commercialization Agreement With Abbisko for Phase III Asset, Pimicotinib

Retrieved on: 
Monday, December 4, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Medicine, Independent Review Committee, Safety, Therapy, RECIST, Disease, Stiffness, Patient, TGCT, Joint, Merck, Tenosynovial giant cell tumor, Partnership, Pain, Swelling, Health care, Merck Group, Pharmaceutical industry, Hong Kong

The agreement grants Merck KGaA, Darmstadt, Germany a license to commercialize pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for rest of world.

Key Points: 
  • The agreement grants Merck KGaA, Darmstadt, Germany a license to commercialize pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for rest of world.
  • In addition, Merck KGaA, Darmstadt, Germany has the option to co-develop pimicotinib in additional indications under certain conditions.
  • Merck KGaA, Darmstadt, Germany will provide Abbisko with an upfront payment of $70 million and upon exercising the option, will provide Abbisko an option fee.
  • Abbisko will receive additional payments for the achievement of certain regulatory and commercial milestones, as well as double-digit tiered royalties on net sales by Merck KGaA, Darmstadt, Germany.

Merck Strengthens Oncology Portfolio Through Commercialization Agreement With Abbisko for Phase III Asset, Pimicotinib

Retrieved on: 
Monday, December 4, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Medicine, Independent Review Committee, Safety, Therapy, RECIST, Disease, Stiffness, Patient, TGCT, Science, Joint, Tenosynovial giant cell tumor, Partnership, Pain, Swelling, Health care, Pharmaceutical industry, Merck, Hong Kong

The agreement grants Merck a license to commercialize pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for rest of world.

Key Points: 
  • The agreement grants Merck a license to commercialize pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for rest of world.
  • The ongoing randomized, double-blind, placebo-controlled Phase III MANEUVER trial is evaluating the efficacy and safety of pimicotinib 50 mg QD in patients with unresectable TGCT.
  • Merck will provide Abbisko with an upfront payment of $70 million and upon exercising the option, will provide Abbisko an option fee.
  • Abbisko will receive additional payments for the achievement of certain regulatory and commercial milestones as well as double-digit tiered royalties on net sales by Merck.

Avstera Therapeutics Announces FDA Clearance of IND Application for AVS100, a Novel Highly Selective HDAC6 Inhibitor Targeting Solid Tumors

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Monday, December 18, 2023
Georgetown University, Tumor-associated macrophage, AMES, Research, GLP, Safety, Therapy, Incidence, RECIST, Toxicology, IND, Risk, Macrophage, Patient, FIH, PFS, MD Anderson Cancer Center, U.S. FDA, FDA, Pembrolizumab, Animal, ICB, SAB, Pharmacokinetics, Marketing, Investigational New Drug, FAAAS, Progression-free survival, ORR, MD, Cancer, MTD, Phase, Doctor of Philosophy, HDAC6, Biomarker, Infrared spectroscopy correlation table, Immunotherapy, Coronavirus Scientific Advisory Board, Neoplasm, Rat, Dog, Government, Pharmaceutical industry, Medicine

AVS100 is a novel, orally bioavailable selective HDAC6i targeting locally advanced or metastatic solid tumors, including in combination with pembrolizumab.

Key Points: 
  • AVS100 is a novel, orally bioavailable selective HDAC6i targeting locally advanced or metastatic solid tumors, including in combination with pembrolizumab.
  • "The FDA clearance of our IND for AVS100 marks an amazing step for our company towards the fulfillment of our mission.
  • "FDA clearance of our IND for AVS100 represents a significant milestone for Avstera's mission in providing state of the art oncological agents to tackle solid tumors.
  • Undoubtedly, the IND approval of AVS100 selective HDAC6 inhibitor will open new opportunities to potentially enhance response rates for patients."

Jazz Pharmaceuticals Presents Updated Phase 2a Data at SABCS 2023 Showcasing Potential of Zanidatamab in HER2+/HR+ Metastatic Breast Cancer

Retrieved on: 
Friday, December 8, 2023
Trastuzumab, Research, Progression-free survival, RECIST, Fulvestrant, Breast cancer, Jazz Pharmaceuticals, Patient, PFS, Part, Corr, DOR, MBC, DCR, Pertuzumab, HER2, Cancer, Vall d'Hebron University Hospital, BS 5839 Part 1, Metastasis, HR, Pharmaceutical industry, Medical imaging, MD

DUBLIN, Dec. 8, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today presented updated data from the Phase 2a trial of investigational zanidatamab, a HER2-targeted bispecific antibody, in combination with palbociclib, a CDK4/6 inhibitor, and fulvestrant, a selective estrogen receptor antagonist, in patients with HER2-positive (HER2+)/HR-positive (HR+) metastatic breast cancer (mBC) as part of a late-breaking oral presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS).

Key Points: 
  • DUBLIN, Dec. 8, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today presented updated data from the Phase 2a trial of investigational zanidatamab, a HER2-targeted bispecific antibody, in combination with palbociclib, a CDK4/6 inhibitor, and fulvestrant, a selective estrogen receptor antagonist, in patients with HER2-positive (HER2+)/HR-positive (HR+) metastatic breast cancer (mBC) as part of a late-breaking oral presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS).
  • Patients treated with the combination regimen received a median of four prior systemic regimens in the metastatic setting (range, 1-12).
  • Recommended doses of the zanidatamab plus palbociclib and fulvestrant combination therapy were determined in Part 1 of the study.
  • Patients treated with the combination regimen achieved a cORR of 35% and DCR of 91%.

Updated clinical safety and efficacy data for iOnctura's roginolisib presented at ESMO Immuno-Oncology Congress 2023

Retrieved on: 
Friday, December 8, 2023
Uveal melanoma, Eye, Malignancy, Safety, Immune-related response criteria, Immune system, RECIST, Disease, Neoplasm, ESMO, Patient, Cancer, Survival, Overalls, NK, Vaccine, Medical imaging, Pharmaceutical industry

Roginolisib is in development for solid and hematologic malignancies including uveal melanoma, a rare cancer of the eye.

Key Points: 
  • Roginolisib is in development for solid and hematologic malignancies including uveal melanoma, a rare cancer of the eye.
  • Mass cytometry data showed treatment with roginolisib led to an increase in activated anti-cancer CD8+ T-cells and natural killer (NK) cells, increased interferon signalling and a decrease in cancer-promoting Regulatory T-cells.
  • Boosting of antitumoral immunity was observed in patients with long-term disease control after roginolisib treatment but not patients with progressive disease.
  • Catherine Pickering, Chief Executive Officer of iOnctura, said: "These safety and clinical efficacy data demonstrate iOnctura's progression of roginolisib.

Updated clinical safety and efficacy data for iOnctura's roginolisib presented at ESMO Immuno-Oncology Congress 2023

Retrieved on: 
Friday, December 8, 2023
Uveal melanoma, Eye, Malignancy, Safety, Immune-related response criteria, Immune system, RECIST, Disease, Neoplasm, ESMO, Patient, Cancer, Survival, Overalls, NK, Vaccine, Medical imaging, Pharmaceutical industry

Roginolisib is in development for solid and hematologic malignancies including uveal melanoma, a rare cancer of the eye.

Key Points: 
  • Roginolisib is in development for solid and hematologic malignancies including uveal melanoma, a rare cancer of the eye.
  • Mass cytometry data showed treatment with roginolisib led to an increase in activated anti-cancer CD8+ T-cells and natural killer (NK) cells, increased interferon signalling and a decrease in cancer-promoting Regulatory T-cells.
  • Boosting of antitumoral immunity was observed in patients with long-term disease control after roginolisib treatment but not patients with progressive disease.
  • Catherine Pickering, Chief Executive Officer of iOnctura, said: "These safety and clinical efficacy data demonstrate iOnctura's progression of roginolisib.

Monopar Therapeutics Reports Third Quarter 2023 Financial Results and Recent Developments

Retrieved on: 
Thursday, November 9, 2023
National University of Singapore, BMI, Actinium-225, ASTS, Doxorubicin, G&A, Kidney, Cell, Receptor (biochemistry), SD, Clinical trial, Hypertension, Cancer, Annual general meeting, Cardiotoxicity, National university, RECIST, Investment, Patient, IPSC, Heart failure, Pharmaceutical industry, Medical imaging, Validation (drug manufacture)

WILMETTE, Ill., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced third quarter 2023 financial results and summarized recent developments.

Key Points: 
  • WILMETTE, Ill., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced third quarter 2023 financial results and summarized recent developments.
  • At the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting, Monopar presented Phase 1b clinical trial results to-date.
  • Results for the Third Quarter Ended September 30, 2023 Compared to the Third Quarter Ended September 30, 2022
    Cash, cash equivalents and short-term investments as of September 30, 2023 were $8.5 million.
  • G&A expenses for the three months ended September 30, 2023 were $749,000, compared to $675,000 for the three months ended September 30, 2022.

Repare Therapeutics Provides Business Update and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 9, 2023
Oncology, Health, Genetics, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Neoplasm, Research, PRS, Carboplatin, Ovarian cancer, Trae Waynes, Traveller Alien Module 2: K'kree, Oncology nursing, Partnership, CBR, September 5, ATR, CCNE1, Circulating tumor DNA, OR, BMS, Paclitaxel, Ono, Clinical Ovarian Cancer & Other Gynecologic Malignancies, Glomus tumor, Roche, Net, Safety, Therapy, Cancer, Patient, DNA, MRR, Conference, Clinical trial, Anemia, IST, AACR, Red Barricades: ASL Historical Module 1, FOLFIRI, Genotype, PPP2R1A, PKMYT1, FBXW7, Princess Margaret Cancer Centre, RECIST, Modularity, PARP, Pharmaceutical industry, Vaccine, Reinsurance, Reparenting, G&A, IND

Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today reported financial results for the third quarter ended September 30, 2023.
  • In the cohort of patients with gynecologic tumors, the RECIST response was 50%, OR was 60%, and CBR was 70%.
  • These patients also had a median of 3 and up to 9 prior lines of therapy, before administration of lunresertib.
  • RP-3467 is Repare’s wholly-owned Polθ inhibitor, currently in IND-enabling studies, which began in the second quarter of 2023 and remain ongoing.